Viewing data from:

FEMARA

NDA

LETROZOLE | N020726 | NOVARTIS PHARMACEUTICALS CORP

1 strength0 unique patents0 unique exclusivities

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

Para IV certification filed but no ANDA patent litigation cases (NOS 835) matched from PACER. Litigation may be pending or filed under a different caption.

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

379 trials from ClinicalTrials.gov — 9 recruiting, 36 active, 220 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Endocrine Therapy With Abemaciclib or Chemotherapy as Initial Metastatic Treatment in ER+/HER2- Breast Cancer NCT04158362	Phase 3	Active	UNICANCER	180	2020-06-11 → 2028-06
A Phase II, Two-Arm Study of Everolimus and Letrozole, +/- Ribociclib (Lee011) in Patients With Advanced or Recurrent Endometrial Carcinoma NCT03008408	Phase 2	Active	M.D. Anderson Cancer Center	90	2017-08-18 → 2028-08-31
Letrozole and RAD001 With Advanced or Recurrent Endometrial Cancer NCT01068249	Phase 2	Active	M.D. Anderson Cancer Center	42	2010-04-30 → 2028-04-30
Extension Study of Lapatinib Plus Herceptin With or Without Endocrine Therapy NCT00999804	Phase 2	Active	Baylor Breast Care Center	128	2011-10 → 2026-01
ExclUsive endocRine Therapy Or Radiation theraPy for Women Aged ≥70 Years Early Stage Breast Cancer NCT04134598	Phase 3	Active	Azienda Ospedaliero-Universitaria Careggi	926	2021-02-08 → 2030-03-31
A Study of Abemaciclib (LY2835219) in Participants With Breast Cancer NCT02763566	Phase 3	Active	Eli Lilly and Company	463	2016-12-05 → 2028-03
S1207 Hormone Therapy With or Without Everolimus in Treating Patients With Breast Cancer NCT01674140	Phase 3	Active	SWOG Cancer Research Network	1,939	2013-09-12 → 2030-01
AKT Inhibitor, Ipatasertib, With Endocrine and CDK 4/6 Inhibitor for Patients With Metastatic Breast Cancer (TAKTIC)NCT03959891	Phase 1	Active	Massachusetts General Hospital	77	2019-05-30 → 2026-07
Study of LEE011, BYL719 and Letrozole in Advanced ER+ Breast Cancer NCT01872260	Phase 1/2	Active	Novartis Pharmaceuticals	255	2013-10-22 → 2027-02-26
PersonaLized neoAdjuvant Strategy ER Positive and HER2 Negative Breast Cancer TO Increase BCS Rate NCT03900637	Phase 2	Active	Seoul National University Hospital	122	2019-11-08 → 2028-12-31

Source: ClinicalTrials.gov. Trials matched by ingredient name.

Drug Pricing (NADAC)

National Average Drug Acquisition Cost — Week of 2026-07-15 | 1 NDC

Highest NADAC/Unit

$27.12

per ea

Lowest NADAC/Unit

$27.12

per ea

Brand NDCs

Generic NDCs

NDC Description	NADAC/Unit	Unit	Type	Generic NADAC	Effective
00078024915FEMARA 2.5 MG TABLET	$27.12	EA	Brand	$0.1535	2026-01-07

Source: NADAC (data.medicaid.gov). Prices reflect national average acquisition costs for retail community pharmacies.

VA Federal Supply Schedule

Government-negotiated contract prices | 2 NDCs (1 FSS, 1 Big4)

Lowest Price

$605.61

Highest Price

$752.18

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
00078-0249-15FEMARA TABLETS	$752.18	FSS	Novartis Pharmaceuticals Corporation	08/31/2026
00078-0249-15FEMARA TABLETS	$605.61	Big4	Novartis Pharmaceuticals Corporation	08/31/2026

Source: VA Federal Supply Schedule (va.gov). Prices are government-negotiated contract prices.

Medicare Part D Spending

CMS annual spending data for Femara (2024)

Total Spending

$1.3M

Total Claims

905

Beneficiaries

208

Avg Cost/Unit

$25.03

Spending Trend

$2.4M(2019)→$2.4M(2020)→$2.0M(2021)→$1.6M(2022)→$1.5M(2023)→$1.3M(2024)

YoY Change:-1.8%

5yr CAGR:+2.3%

Source: CMS Medicare Part D Spending by Drug (2024). Shows gross drug cost under Part D.

API Supply Chain13 active DMFs13 inactive

11 active API suppliers hold Drug Master Files for this ingredient.

NATCO PHARMA LTDLETROZOLE

DMF 183882005

SCINOPHARM TAIWAN LTDLETROZOLE

DMF 191392006

CIPLA LTDLETROZOLE USP

DMF 201752008

TAPI NL BVLETROZOLE USP NON-STERILE BULK DRUG SUBSTANCE

DMF 205662007

DR REDDYS LABORATORIES LTDLETROZOLE

DMF 210362007

TAPI NL BVLETROZOLE

DMF 211822007

SYNTHIMED LABS PRIVATE LTDLETROZOLE USP

DMF 220932008

SUN PHARMACEUTICAL INDUSTRIES LTDLETROZOLE USP

DMF 226322009

NATCO PHARMA LTDLETROZOLE (LER)

DMF 228122009

HETERO LABS LTDLETROZOLE USP

DMF 248862011

SHILPA PHARMA LIFESCIENCES LTDLETROZOLE USP

DMF 274892013

WANYANG HENGSHUI PHARMACEUTICAL CO LTDLETROZOLE

DMF 394232024

ZYDUS LIFESCIENCES LTDLETROZOLE USP

DMF 407462024

ALCAMI WISCONSIN CORPInactiveLETROZOLE, USP

DMF 191702006

OLON SPAInactiveLETROZOLE DRUG SUBSTANCE

DMF 196222006

SANMAR SPECIALITY CHEMICALS LTDInactiveLETROZOLE USP

DMF 200202006

ZHEJIANG HISUN PHARMACEUTICAL CO LTDInactiveLETROZOLE USP

DMF 203562007

TAI HENG INDUSTRY CO LTDInactiveLETROZOLE USP

DMF 207612007

FRESENIUS KABI ONCOLOGY LTDInactiveLETROZOLE

DMF 211912008

CADILA HEALTHCARE LTDInactiveLETROZOLE USP

DMF 214622008

USV PRIVATE LTDInactiveLETROZOLE USP

DMF 222392008

MYLAN LABORATORIES LTDInactiveLETROZOLE USP

DMF 234112009

JIANGSU HENGRUI PHARMACEUTICALS CO LTDInactiveLETROZOLE USP NON-STERILE BULK DRUG SUBSTANCE

DMF 238312010

APOTEX PHARMACHEM INDIA PVT LTDInactiveLETROZOLE USP

DMF 250692011

SICHUAN XIELI PHARMACEUTICAL CO LTDInactiveLETROZOLE

DMF 262522012

MAC CHEM PRODUCTS INDIA PVT LTDInactiveLETROZOLE USP

DMF 265502012

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

18 letters from Drugs@FDA

Date	Submission	Document
Dec 18, 2024	SUPPL -43	View Letter (PDF)
Apr 6, 2018	SUPPL -35	View Letter (PDF)
Jul 17, 2017	SUPPL -33	View Letter (PDF)
Jan 17, 2014	SUPPL -27	View Letter (PDF)
Jan 3, 2012	SUPPL -24	View Letter (PDF)
Jun 29, 2010	SUPPL -19	View Letter (PDF)
May 6, 2010	SUPPL -20	View Letter (PDF)
Mar 8, 2010	SUPPL -15	View Letter (PDF)
Mar 8, 2010	SUPPL -16	View Letter (PDF)
Jul 17, 2009	SUPPL -18	View Letter (PDF)
Aug 13, 2008	SUPPL -17	View Letter (PDF)
Apr 20, 2007	SUPPL -14	View Letter (PDF)
Jun 27, 2006	SUPPL -13	View Letter (PDF)
Jan 6, 2006	SUPPL -12	View Letter (PDF)
Jan 26, 2005	SUPPL -11	View Letter (PDF)
Jun 4, 2004	SUPPL -8	View Letter (PDF)
Mar 10, 2003	SUPPL -5	View Letter (PDF)
Jan 10, 2001	SUPPL -6	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 2.5MG

RLDAB

0 patents0 exclusivities▴

TABLET;ORAL | Approved: Jul 25, 1997

No patent or exclusivity listings for this strength.